Profile: The Binding Site Group Limited specializes in the research, development and manufacture of immunodiagnostic assays in the fields of multiple myeloma & investigation of the immune response. Hevylite™ is our panel of immunoassays using polyclonal antibodies targeted at the junctional epitopes between the heavy chain and light chain constant regions of intact immunoglobulins. It is used in monitoring patients with multiple myeloma and other B cell dyscrasias. The Minineph™ is a bench top laser nephelometer capable of performing a range of quantitative serum protein assays. It is suitable as an alternative method to radial immunodiffusion (RID) and other manual techniques, or to back up a main analyzer by performing low volume tests.

The company was founded in 1983.

FDA Registration Number: 9614373
US Agent: Doug Kurth / The Binding Site Inc
Phone: +1-(800)-633-4484  Fax: +1-(858)-453-9189  E-Mail:

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• Albumin Antigen Antiserum Control (FDA Code: DCF / 866.5040) An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

• Albumin, FITC Conjugate (FDA Code: DDZ / 866.5040)

• Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.5420) Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

• Alpha-1-Antitrypsin (FDA Code: DEM / 866.5130) Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Anti-DNA Indirect Immunofluorescent Solid Phase (FDA Code: KTL / 866.5100) An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Anti-kappa Antiserum (FDA Code: DFH / 866.5550) An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

• Antibodies to Glomerular Basement Membrane (gbm) Measure Devices (FDA Code: MVJ / 866.5660) A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100)

• Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 866.5660)

• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 866.5100)

• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720)

• Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060) An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• B2 - Glycoprotein I Antibodies Test System (FDA Code: MSV / 866.5660)

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630) Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• Ceruloplasmin (FDA Code: DDB / 866.5210) A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

• Complement C1q (FDA Code: DAK / 866.5240) A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Complement C1s (FDA Code: DBA / 866.5250) A complement C1inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1inhibitor (a plasma protein) in serum. Complement C1inhibitor occurs normally in plasma and blocks the action of the C1component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

• Complement C3 (FDA Code: CZW / 866.5240)

• Complement C4 (FDA Code: DBI / 866.5240)

• Complement C5 (FDA Code: DAY / 866.5240)

• Complement C9 (FDA Code: DAE / 866.5240)

• Cystatin C Test (FDA Code: NDY / 862.1225) A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160) A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Electrophoresis Apparatus (FDA Code: JJN / 862.2485) An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.

• Endomysial Autoantibodies (FDA Code: MVM / 866.5660)

• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100)

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)

• Fibrinogen Determination System Test (FDA Code: KQJ / 864.7340) A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Fitc Haptoglobin Antiserum Antigen Control (FDA Code: DAB / 866.5460) A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• Gamma Chain Specific Control (FDA Code: DFZ / 866.5510) An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• General Purpose Reagent (FDA Code: LDT)

• Gliadin Antibodies (FDA Code: MST / 866.5750) A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

• Goat Antibody Morphine-Barbiturate (125-I) RIA Test (FDA Code: DNA / 862.3640) A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

• Haemophilus Influenza Antiserum (FDA Code: GRP / 866.3300)

• Haptoglobin (FDA Code: DAD / 866.5460)

• IGA Control (FDA Code: CZP / 866.5510)

• Igal Heavy & Light Chain Combined (FDA Code: OPY / 866.5510)

• IgD Antisera (FDA Code: CZJ / 866.5510)

• IgE Control (FDA Code: DGC / 866.5510)

• IgG Control (FDA Code: DEW / 866.5510)

• Immunoelectrophoretic, Immunoglobulins (G, A, M) (FDA Code: CFF / 866.5510)

• Immunoglobulin A Kappa Heavy & Light Chain Combined (FDA Code: OPX / 866.5510)

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860) Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660)

• Indirect Immunofluorescent Antimitochondrial Antibody Test (FDA Code: DBM / 866.5090) An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

• Indirect Immunofluorescent Multiple Auto Antibody (FDA Code: DBL / 866.5660)

• Kappa FITC (FDA Code: DEO / 866.5550)